isoniazid

Generic: isoniazid

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoniazid
Generic Name isoniazid
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isoniazid 300 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-395
Product ID 71610-395_10b9b8c8-0cfc-47b7-9324-bbd6f2617b5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080937
Listing Expiration 2026-12-31
Marketing Start 1972-09-01

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610395
Hyphenated Format 71610-395

Supplemental Identifiers

RxCUI
197832
UNII
V83O1VOZ8L
NUI
N0000175483

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name isoniazid (source: ndc)
Generic Name isoniazid (source: ndc)
Application Number ANDA080937 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (71610-395-30)
source: ndc

Packages (1)

71610-395-30 30 TABLET in 1 BOTTLE, PLASTIC (71610-395-30)

Ingredients (1)

isoniazid (300 mg/1)

Linked Drug Pages (1)

Isoniazid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "10b9b8c8-0cfc-47b7-9324-bbd6f2617b5f", "openfda": {"nui": ["N0000175483"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832"], "spl_set_id": ["cb6f5638-2d3a-4334-b272-6b4772d32d03"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (71610-395-30)", "package_ndc": "71610-395-30", "marketing_start_date": "20200221"}], "brand_name": "Isoniazid", "product_id": "71610-395_10b9b8c8-0cfc-47b7-9324-bbd6f2617b5f", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "71610-395", "generic_name": "Isoniazid", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isoniazid", "active_ingredients": [{"name": "ISONIAZID", "strength": "300 mg/1"}], "application_number": "ANDA080937", "marketing_category": "ANDA", "marketing_start_date": "19720901", "listing_expiration_date": "20261231"}